Pyelonephritis
Conditions
Keywords
Acute Pyelonephritis, Acetylcysteine, Pediatric
Brief summary
In different studies, it has been shown that antioxidant utilization has favorable therapeutic effects not only on control of acute symptoms but also on prevention of delayed problems from acute and chronic pyelonephritis. According to the efficacy of acetylcysteine as a potent antioxidant, safety of this drug and side effects of similar or either less than placebo, this study was designed to evaluate the efficacy of this drug on inflammatory biomarkers of pediatric acute pyelonephritis. It is a triple-blind placebo controlled study on a population of 64 patients 1-16 years old that have definite or probable diagnosis of acute pyelonephritis in Mofid hospital. After randomization, patients will be given acetylcysteine or placebo with dosing according to their weight. Results of treatment are evaluated according to serum procalcitonin, C reactive protein and leukocyte count before drug prescription (baseline) and 5 days after drug prescription. Side effects are also recorded in both groups. Patients will be receiving their routine antimicrobial drugs in addition to acetylcysteine.
Interventions
DRUGAcetylcysteine
DRUGplacebo acetylcysteine
Sponsors
Shahid Beheshti University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Patients between the ages of 1 and 16 * Having the diagnosis of definite or probable urinary tract infection according to guidelines of pediatric infectious disease research center
Exclusion criteria
* Patients younger than 1 or older than 16 years old * Patients without the diagnosis of definite or probable urinary tract infection according to guidelines of pediatric infectious disease research center * Patients with acute/ chronic infectious or inflammatory diseases other than pyelonephritis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum procalcitonin | Change from baseline serum procalcitonin at 5 days |
Secondary
| Measure | Time frame |
|---|---|
| Serum C Reactive Protein | Change from baseline serum C Reactive Protein at 5 days |
| Leukocyte count | Change from baseline leukocyte count at 5 days |
| Probable adverse effects (nausea, vomiting, bad tasting, stomatitis, ...) | Participants will be followed for the duration of hospital stay, an expected average of 5 days |
Countries
Iran
Outcome results
None listed